A PMTA submission requires a substantive dossier to be submitted to FDA. Compiling a dossier requires extensive expertise in the PMTA process and multidisciplinary scientific areas such as toxicology, physiology, chemistry, biochemistry, environmental assessment, and psychology.
Our regulatory consultants have deep experience compiling PMTA dossiers and have worked on several projects that received Marketing Orders. They are experienced in using the eTTD format, which reduces time and costs when making amends or future submissions to FDA. Having worked on several successful PMTAs, our scientific and regulatory consultants understand where the threshold has been set by FDA for providing sufficient evidence of Appropriateness for the Protection of Public Health (APPH).